Product category · Updated Jul 29, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices ranks #1 of 12 among PlainRecalls categories by recall count (40,910 notices, 39.3% of the archive); 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,910 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,158-record archive. Among 12 product categories, that is #1 of 12. Of the 40,910 records graded for severity, 9% are high-severity. Most are issued by FDA Devices. Counts reflect market size and reporting activity, not a product's inherent danger.
- 40,910 total recalls
- #1 of 12 among categories
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
According to PlainRecalls' category ranking (distinct recall events, same sort as /category), Medical Devices is #1 of 12 (1st of 12) with 40,910 recalls, about 39.3% of the 104,158-record federal archive, with 3,645 graded high-severity, most issued by FDA Devices.
- 40,910
- total recalls
- #1 of 12
- category rank by events
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
Where Medical Devices sits among all 12 categories
Distinct recall-event inventory across every PlainRecalls product category. Medical Devices is marked; archive size reflects reporting volume, not inherent product danger.
Medical Devices vs all categories by recall count
Where this category's archive sits among every tracked product class
40,910 1st of 12 the highest of 12 categories
Categories, banded by distinct recall-event inventory
Each bar is a band; taller bars hold more categories. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · NHTSA federal recall filings · 2026-08-29
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,645
High severity
3,645 recalls
- Moderate
Moderate
36,211 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,635 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 306
CPSC
306 recalls
- FDA Food 35
FDA Food
35 recalls
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Recalls in Medical Devices
Newest first · Page 624 of 819
EndoVive 3s Low Profile Balloon Kits Part Number: M00548780 (XMD P/N 70-0050-D20) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics Corp.
9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131 Defibri…
Cardiac Science Corporation
Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics Corp.
Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics Corp.
EndoVive 3s Low Profile Balloon Kits Part Number: M00548870 (XMD P/N 70-0050-620) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548700 (XMD P/N 70-0050-518) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis
Fresenius Medical Care Renal Therapies Group, LLC
EndoVive 3s Low Profile Balloon Kits Part Number: M00548770 (XMD P/N 70-0050-C18) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548600 (XMD P/N 70-0050-B16) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics Corp.
CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femoral prosthesis, knee, patello/femorotibial, semi-constrained, uncemente…
Zimmer Biomet, Inc.
Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter…
Cook Inc.
EndoVive 3s Low Profile Balloon Kits Part Number: M00548540 (XMD P/N 70-0050-516) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00549440 (XMD P/N 70-0050-E22) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00549480 (XMD P/N 70-0050-424) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 Product Usage: The Weck Auto Endo5 hem-o-l…
Teleflex Medical
Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope
Integrated Medical Systems Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548960 (XMD P/N 70-0050-F20) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope
Integrated Medical Systems Inc
Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope
Integrated Medical Systems Inc
Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasi…
Hill-Rom, Inc.
Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated ca…
Cook Inc.
LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Various sizes¿ Product Usage "" This de…
Zimmer Biomet, Inc.
EndoVive 3s Low Profile Balloon Kits Part Number: M00548810 (XMD P/N 70-0050-G18) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548440 (XMD P/N 70-0050-B14) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope
Integrated Medical Systems Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548660 (XMD P/N 70-0050-118) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548450 (XMD P/N 70-0050-C14) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00549310 (XMD P/N 70-0050-122) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548480 (XMD P/N 70-0050-F14) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00549600 (XMD P/N 70-0050-G24) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548330 (XMD P/N 70-0050-014) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00549580 (XMD P/N 70-0050-E24) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope
Integrated Medical Systems Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00549520 (XMD P/N 70-0050-824) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548800 (XMD P/N 70-0050-F18) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548460 (XMD P/N 70-0050-D14) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, poly…
Zimmer Biomet, Inc.
BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen. Product Usage: …
Becton, Dickinson and Company, BD Biosciences
EndoVive 3s Low Profile Balloon Kits Part Number: M00548720 (XMD P/N 70-0050-718) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00549330 (XMD P/N 70-0050-322) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548340 (XMD P/N 70-0050-114) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
Synthes Small Electric Drive (SED)
The Anspach Effort, Inc.
EndoVive 3s Low Profile Balloon Kits Part Number: M00548900 (XMD P/N 70-0050-920) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
Olympus, Model No. XCF-Q160ALE, flexible scope, large diameter, video colonoscope
Integrated Medical Systems Inc
ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various sizes These devices are indicat…
Zimmer Biomet, Inc.
EndoVive 3s Low Profile Balloon Kits Part Number: M00549340 (XMD P/N 70-0050-422) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548510 (XMD P/N 70-0050-216) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548620 (XMD P/N 70-0050-D16) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
What to do with this
Monitoring medical devices? Start here.
- Check a specific product against the full federal archive before you use or buy it. Recall checker
- Most medical devices recalls come from FDA Devices - browse that agency's full feed. FDA Devices recalls
- Sort the whole archive by severity to see the highest-risk active recalls first. Rankings
Recall categorization follows the issuing agency's product taxonomy; always confirm specifics on the official notice.
Nearby categories
Adjacent product categories that share hazard patterns or regulatory oversight.
Data sources
- Source: FDA - openFDA Enforcement API (food, drug, and device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls
- Source: NHTSA - National Highway Traffic Safety Administration Recalls (vehicles & equipment)
Category data as of Jul 29, 2026.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Category counts and the year trend are computed across the full archive for medical devices. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of Jul 29, 2026.